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Study on the Effectiveness and Safety of 0.1% Mometasone Furoate Emulsion and Ecural Cream for Adults with Plaque Psoriasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of plaque psoriasis, a common skin condition that causes red, scaly patches on the skin. The study will evaluate the effectiveness and safety of a treatment called 0.1% mometasone furoate cutaneous emulsion, which is a type of medication applied to the skin. This treatment will be compared to a similar product called Ecural Fettcreme and a placebo, which is a version of the treatment without the active ingredient.

The purpose of the study is to determine if the mometasone furoate cutaneous emulsion is as effective as the Ecural Fettcreme in treating plaque psoriasis and to see if it works better than the placebo. Participants in the study will apply the treatments to their skin over a period of three weeks. The study will involve regular assessments to monitor changes in the skin condition, focusing on improvements in redness, thickness, and scaling of the affected areas.

Throughout the study, participants will be observed to ensure their safety and to track the effectiveness of the treatments. The goal is to find a reliable and safe treatment option for individuals with plaque psoriasis, improving their quality of life by reducing the symptoms associated with this skin condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, gender, and the presence of stable plaque psoriasis.
Two comparable psoriatic areas on the body are identified for treatment, ensuring they meet the required size and severity conditions.
Step 2
Treatment initiation
The treatment involves the application of a 0.1% mometasone furoate cutaneous emulsion to one of the selected psoriatic areas.
A placebo (an inactive substance) is applied to the other area for comparison.
The treatment is applied topically, meaning it is applied directly to the skin.
Step 3
Treatment duration
The treatment is administered over a period of 22 days.
The application is done according to the instructions provided, ensuring consistent and correct use.
Step 4
Monitoring and assessment
The effectiveness of the treatment is evaluated by measuring changes in the Total Sign Score (TSS), which assesses redness, thickness, and scaling of the skin.
Primary assessment occurs on Day 22, with additional evaluations on Day 8 to monitor progress.
Step 5
Completion of the trial
Upon completion of the treatment period, final assessments are conducted to determine the overall effectiveness and safety of the treatment.
The results contribute to understanding the treatment's impact on plaque psoriasis.

Who can join the trial?

6 criteria

Men and women who are not pregnant or breastfeeding, aged between 18 and 65 years.
Individuals with a confirmed diagnosis of stable plaque psoriasis. The condition should be mild at the start, affecting no more than 10% of the body surface area (BSA), with a Psoriasis Area and Severity Index (PASI) score of 10 or less, and a Dermatology Life Quality Index (DLQI) score of 10 or less.
Participants must have two similar areas of psoriasis for treatment on the arms, legs, or body (either on both sides, like both elbows, or on one part of the body if they are at least 3 cm apart, like the upper and lower back). The larger area should not be more than twice the size of the smaller area. Areas on the face, scalp, neck, palms, soles, and skin folds cannot be chosen for treatment.
Participants should have a similar baseline Total Sign Score (TSS), which is a combined score for redness, thickness, and scaling, of at least 6 out of 9 for each selected area. The difference in TSS between the two target areas should not be more than 2 grades.
Women who can have children must either be permanently unable to have children or agree to use a highly effective birth control method (with a failure rate of 1% or less per year when used correctly) during the clinical trial.
Participants must provide written informed consent, which means they agree to take part in the study after being fully informed about it.

Who cannot join the trial?

8 criteria

Patients who are not within the specified age range for the study.
Patients who have medical conditions other than plaque psoriasis, which is a skin condition that causes red, scaly patches.
Patients who are part of a vulnerable population, meaning they might need special protection or care.
Patients who are not able to follow the study procedures or instructions.
Patients who are currently participating in another clinical trial.
Patients who have used certain medications that might interfere with the study results.
Patients who have a history of allergic reactions to the study treatments.
Patients who have any other health issues that the study doctors think might make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Provita Sp. z o.o.
Katowice, Poland

Trial locations

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Investigated drugs

Mometasone Furoate Cutaneous Emulsion
is a topical medication used in this trial to treat plaque psoriasis. It is applied directly to the skin and works by reducing inflammation, redness, and itching associated with psoriasis. The goal of the trial is to determine if this emulsion is as effective as other treatments in managing the symptoms of psoriasis.
Ecural® Fat Cream
is another topical treatment used in the trial for plaque psoriasis. It is applied to the skin to help reduce the symptoms of psoriasis, such as redness, thickening, and scaling. The trial compares this cream to the mometasone furoate emulsion to evaluate their effectiveness in treating psoriasis.

What is already known about the treatment

Mometasone Furoate – This medication is administered as a topical emulsion applied directly to the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating plaque psoriasis. The main therapeutic indication is for the management of plaque psoriasis, a chronic skin condition characterized by red, scaly patches. Mometasone furoate works by reducing inflammation and suppressing the immune response at the molecular level, which helps to alleviate symptoms. It is classified as a corticosteroid, a type of medication commonly used to reduce inflammation in various conditions.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that primarily affects the skin, leading to the development of raised, red patches covered with a silvery white buildup of dead skin cells. These patches, known as plaques, can appear anywhere on the body but are most commonly found on the elbows, knees, scalp, and lower back. The condition is characterized by cycles of flare-ups and remission, where symptoms may improve or worsen over time. The skin lesions are often itchy and can be painful, sometimes cracking and bleeding. The exact cause of plaque psoriasis is not fully understood, but it involves an overactive immune response that accelerates the growth cycle of skin cells. Environmental factors, stress, and certain medications can trigger or exacerbate the symptoms.